Evaxion Biotech A/S (EVAX) Q2 2026 Earnings Report, Transcript and Summary

Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Second Quarter 2026 Financial Results. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Helen Tayton-Martin, CEO. Please go ahead.

Thank you, speaker. I'm Helen Tayton-Martin. I'm the Chief Executive of Evaxion, and we're delighted today to be presenting our Q2 business update. I'm joined today on the call by Birgitte Rono, our CFO and COO, who will provide an overview of our updates in our R&D pipeline and AI-Immunology platform. Then I'll hand over to Thomas Schmidt, who will talk through our Q2 financial results before we bring it back to conclusions and Q&A. So first, of course, we may make forward-looking statements, and the audience is advised to look at our recently filed SEC documents. And now I'll kick off the discussion. So really, Q2 has been marked by a series of achievements in our 4 core areas or 4 core platforms for the company. First of all, just focusing on business development. As previously and ongoing through the course of this year, there are many discussions we are having with partners regarding the Evaxion programs and pipeline. We've had a new stream of very encouraging new data, which continues to come through and continuously validate the AI-Immunology platform, which really feeds into those various conversations, and we'll touch on some of those today. And in particular, in our R&D area, we have been very pleased to be accepted to present further updates on our EVX-01 program, our personalized neoantigen cancer vaccine in advanced melanoma patients. And obviously, it was a great day for the field yesterday to see the positive Phase III results from the similar Moderna and Merck program in personalized cancer vaccine in melanoma produced. And so it will be great for us and the field to talk more about that as we head into ESMO and an update on our own data there. Elsewhere, we have been working to refocus and expand the pipeline, leveraging our learnings with our EVX-03 and EVX-01 platform actually into a new program, which we call, EVX-05 in glioblastoma where we are further leveraging the ERVs that we have been able to identify highly conserved ERV antigens for glioblastoma, building on what we have done in our EVX-04 program using a similar approach to use AI-Immunology to find highly conserved ERV antigens in AML. So we presented new preclinical data on that earlier this year at the European Hematology Association Annual Conference. And we've also updated in our infectious disease portfolio on our EVX-V1 CMV program too at the recent HSV, Herpes Simplex Conference last month. More broadly, on AI-Immunology, the platform itself, we were really delighted to see that recognized in the Galien UK Award, a second Galien award we have had for the technology in the last 12 months. So very exciting to see that being recognized more broadly, more globally in terms of the value in AI-Immunology prediction for our programs in infectious disease, oncology, and autoimmune disease. And finally, in terms of the core of our updates, we have maintained a disciplined focus on our resource allocation, really strongly aligned to where we can build the most value from the platform. And with that discipline, we can confirm that our cash runway remains unchanged with the cash at hand to fund our operations into the second half of 2027, and Thomas will talk more about that. So just a reminder before we jump into it, our pipeline consists of a number of programs in cancer and infectious disease at the current time. EVX-01 will be a focus for Birgitte's presentation in a few moments and obviously, also including our EVX-04 and EVX-05 programs, which are focused on the conserved off-the-shelf antigen vaccines. In infectious diseases, we have a number of preclinical programs there, and some of which are partnered, one with Merck, one with Afrigen, and data is continuing to build around the interest that we have on those programs from partners. So in terms of where we are as we meet the halfway point of 2026, we have already met the first of our milestones in terms of updating on the EVX-01 platform at AACR earlier this year with biomarker and immunogenicity preclinical data alongside the clinical data from year 2 at ESMO last year. We have mentioned already, and we will be updating on the 3-year data from that program with efficacy results at ESMO in October. And in the rest of this course of this year, we will be talking more about the application of AI-Immunology in autoimmune disease as well as planning for the regulatory filing of that EVX-04 program, the off-the-shelf program in AML. And finally, we will have an update on our Group A Strep program with the design and preclinical validation of antigens in the EVX-B4. And we continue to prosecute a partnership approach around these programs and platforms where we see value creation. So with that, I'll hand over to Birgitte, who will talk you through our R&D and AI-Immunology update.

Thank you, Helen. So today, I'll focus on our lead asset, EVX-01, our personalized neoantigen cancer vaccine currently in Phase 2 in advanced melanoma. Then I'll present our new off-the-shelf EVX-05 vaccine program, demonstrating the scalability of our AI-Immunology platform into the hard-to-treat and deadly brain cancer, glioblastoma. Lastly, I'll showcase how AI-Immunology identified T cell epitopes are relevant in controlling CMV infections. So as Helen mentioned, we will present 3-year EVX-01 Phase 2 outcome data at the ESMO Congress in October. And this data includes evaluation of the vaccine's effect as stand-alone and also in combination with anti-PD-1 treatment. The data will potentially give further insight into enhanced treatment effects and also the durability of EVX-01 induced immune responses. And collectively, these data provide a more comprehensive assessment of the full potential of EVX-01, strengthening the already strong clinical data package. So looking back at previously announced data from the EVX-01 Phase 2 trial, we reported strong EVX-01-induced immune activation at the AACR Meeting in April. So we were able to show that 86% of the EVX-01 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than what has been reported for other similar vaccine candidates. Furthermore, we also showed that 86% of the immunogenic vaccine targets induced a de novo T cell response, meaning that EVX-01 specifically triggers novel T cell responses rather than amplifying existing responses. And this is very important as induction of de novo T cell responses has been linked to clinical benefit. And at the ESMO Congress last year, we reported 2-year outcome data, including a 75% overall response rate, 25% complete responses, and 92% of the patients still being in response, indicating durable clinical benefit. And importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. So over the last approximately 10 years, personalized neoantigen vaccines have shown promise across several early-phase clinical studies. And with the Moderna and Merck announcement yesterday, we can definitely say that the field is moving from promising experimental immunotherapy towards a clinically validated therapeutic modality with a clear and realistic path to regulatory approval. And these data are not just only a win for Moderna and Merck, but it's a win for the entire field as they broadly validate the personalized neoantigen vaccine concept. So overall, with our encouraging EVX-01 data and with the validation from Moderna and Merck, we believe that we are well-positioned as we move forward towards further value creation. And so let's turn our focus to our off-the-shelf cancer vaccine programs. So in collaboration with Duke University, we are developing an off-the-shelf vaccine, EVX-05 for glioblastoma or GBM, targeting conserved antigens as announced earlier this week. So GBM is the most common and most aggressive primary malignant brain tumor. And despite surgery followed by chemoradiation, outcomes remain very poor with a median overall survival of approximately 1 year, underscoring a significant unmet medical need. So our EVX-05 approach builds on the same novel and broadly applicable concept as EVX-04 as it is designed with AI-Immunology to target conserved tumor-specific antigens derived from endogenous retrovirus elements or ERVs, which are part of the dark genome. The target selection process allows for broad tumor coverage despite immune and tumor antigen differences across patients. So we have applied AI-Immunology, so our AI-powered target discovery approach, and identified an optimal set of ERV fragments based on cross-patient relevance and immunogenic potential. And we have mined patient sequencing data identifying approximately 1.5 million ERV fragments and selected 16 of these as the fragments that will be included in the EVX-05 vaccine. So next steps include lead candidate selection and IND-enabling activities prior to a first-in-human study that is expected to be conducted in collaboration with the world-leading GBM experts we are collaborating with at Duke University. So our other off-the-shelf cancer vaccine program, EVX-04, is also progressing well. So EVX-01 targets multiple conserved ERVs, in the case of this program identified in AML patient samples. So as Helen mentioned, we presented novel data at the European Hematology Association Congress in June, demonstrating that the EVX-04 vaccine is expressed and secreted by human cells, enabling immune recognition and activation. So further, we showed that the 16 ERV targets included in the EVX-04 vaccine activates human immune cells across different HLA types and that these ERV-reactive immune cells can mediate targeted cell killing, indicating not only immune recognition, but also relevant functional impact of these vaccine-induced immune cells. So collectively, these data highlights EVX-04's potential as a new effective therapeutic cancer vaccine. And we look forward to reporting further data as the program progresses towards regulatory filing later this year. So another promising program presented at a scientific conference during the summer is our EVX-V1 cytomegalovirus or CMV vaccine program. So in EVX-V1, we are using AI-Immunology to design known targets, so optimizing them, and also to identify previously unexplored vaccine targets. And at the International Herpesvirus Workshop in July, we presented new data demonstrating that T cell epitopes discovered with AI-Immunology have the potential to control acute infection, latency, and also reactivation in CMV-infected mice. And this is a key finding as it complements previous results, demonstrating the ability of both novel and optimized known B-cell antigens to reduce viral infection. And the data will guide antigen selection for a broadly protective CMV vaccine candidate and as such, represent a very important step forward for the EVX-V1 program. So having highlighted progress across our key R&D programs, let's now focus on our AI-Immunology platform and the data validating its ability to generate high-quality product candidates. So AI-Immunology is clinically validated with positive outcome in 3 out of 3 oncology trials. Preclinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer with our ERV-targeting vaccines as well as in infectious diseases with several candidates against bacterial and viral pathogens. And importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. And additionally, the novel ERV-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. So finally, AI-Immunology supports multiple modalities, including peptides, recombinant proteins, DNA, and RNA platforms, enabling both pipeline and partnering potential. So in conclusion, we have demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress. So with that, I'll hand over to Thomas, who will present our quarterly financial results.

Perfect. Thank you, Birgitte. And let me jump straight into the presentation of the financial results for the second quarter of 2026. The main highlights to start with for the quarter is that we have indeed continued our disciplined resource allocation throughout our strategy direction, of course, and certainly also very much aligned to the priorities around value drivers that we have defined and also communicated earlier for this year. So full alignment and full progress on those elements. We are certainly also on track to deliver according to our financial plan, which both shows in the Q2 results, but certainly also confirmed from the cash position that we do have. And the cash position, we can reconfirm, as mentioned by Helen already, that we have a cash runway that runs into the second half of 2027. So reconfirmed and maintained from earlier communication also. Looking a little bit closer to our profit and loss statement for the quarter. Overall, we see slightly reduced operating expenses, mainly driven from our general and administration costs or the G&A costs, where we have significantly lower capital market costs in Q2 compared to the same period last year. On the R&D front, expenses do show a slight increase versus last year, but it's fully aligned with all the progress that Birgitte just mentioned on EVX-01, EVX-04, EVX-05. And again, also those programs are confirmed within our cash runway until the half year 2027. We reported a net loss for the period of $3.7 million, again, as mentioned already, on plan and following the execution that we've set for this year. Balance sheet. We have a cash position at the end of the quarter of $14 million. We are again reconfirming our cash runway, and the equity that we also have reflects the result for the first 6 months, meaning that we are at $9.5 million at the end of the second quarter, reflecting that versus last year of the net result. So all in all, a good financial performance aligned with expectation and certainly aligned with the progress of our platform and portfolio. And with that, I hand it back to Helen for some concluding remarks.

Thanks, Thomas, and thanks, Birgitte. So in conclusion, I would want to emphasize that we've seen some really good operational momentum on our set milestones and actually with a new program emerging with EVX-05 from all of our activities, but still maintaining our cash runway into the second half of 2027. We're really excited by the stream of new data that we've continued to generate with the team that continues to validate that AI-Immunology can deliver products -- meaningful products for future development. And that is the core underneath all of our ongoing business development discussions as we continue to process which programs we will bring forward and with which partners. So with that, we are very happy to take questions, and thank you for your attention.

[Operator Instructions] And this question comes from Thomas Flaten from Lake Street Capital Markets.

Just 2 questions on EVX-05. I was curious if you could perhaps delineate when we might expect to see some more news out of that program. And then if you could elaborate a little bit on the specific role that Duke played in the development up to date?

Sure. Birgitte?

Yes. So the collaboration with Duke has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinic. So we received sequencing data for some of those, and we're able to identify -- first, we did our personalized approach looking into the profiles of the ERV and neoantigen expression. And then as EVX-04 were in parallel progressing and this off-the-shelf concept we're developing, we were able to use some of the same approaches and analyze the samples for identifying conserved ERVs. And we were very pleased to see that across these many patients, there were shared features indicating that we could definitely generate an off-the-shelf or design an off-the-shelf therapy. It's still, as I mentioned, a bit early in the development path. We have conducted and concluded on what we would call target discovery, so selecting the targets that will be included in the vaccine, and we are now heading towards lead selection. We have designed several different candidates that are now being experimentally tested. And then it's the classical path with IND-enabling activities and then the first-in-human study. We have not yet settled entirely on a timeline for all of these activities, but that's what we are working on at the moment.

So more to come.

More to come, definitely.

We are now going to move to our next question, and this one comes from RK from H.C. Wainwright.

There are a few questions from me, but let me -- hopefully, I could go one at a time. Starting off on EVX-01, obviously, it was exciting to see yesterday's news from the Merck and Moderna collaboration because it validates the program that you have been working on for a while now. So going into ESMO for the 3-year EVX-01 extension data, Birgitte, what would you consider a clinically meaningful durability result that -- especially in the stand-alone vaccine period? And how would that help your discussions with either the partners that are currently looking at this program or even the AI model itself that helped generate EVX-01 on a broader perspective?

Yes. So for the EVX-01 clinical data that we would like to see at ESMO is basically that we have almost the same or even improved overall response rate. So we should remember that these patients, advanced melanoma patients, if they only receive checkpoint inhibitors, then almost half of them by the 5-year mark is actually are having a severe disease or even, yes, passed away. So there is definitely a high unmet medical need for these patients. So we would like to see that we have durable responses. So the same number of patients remains in response at the 2-year mark and further that the T cell responses are maintained. So that is -- we would consider that as positive data, positive outcome of this extension phase. And then you had an additional comment around how this data would potentially support partnership discussions. Yes. So there's no doubt that the more data -- positive data we can generate would be appreciated in these discussions. And I think the validation that came out yesterday of the personalized cancer vaccine concept definitely also is supportive in -- or supports us in these discussions. We have been waiting -- the whole field has been waiting for these Phase III data for a long time. And it's not just a win for the Moderna and Merck, but it's actually a win for the whole field. So definitely, we see this as very encouraging and positive and not just, yes, bad competitor news. It's very positive.

Perfect. Then going on to the off-the-shelf molecule, EVX-04. In terms of getting it ready to get into the clinic, what are the gating steps here? Is it manufacturing? Is it CMC or making sure that you have enough investigators who would do the right thing when you start taking this into the clinic?

Yes. So EVX-04 is we have done target discovery. We have selected the lead. And now we are conducting IND-enabling activities. So that includes the GMP manufacturing. And then, of course, we need to check that the molecule that is produced is also capable of driving a strong immune response. And then at the same time, we're also engaging with the clinical sites, ensuring that we have a setup for testing the EVX-04 molecule. We plan to take this program into the clinic, but we are, of course, always interested and are engaging with companies. So yes, but it's not necessarily dependent on us entering into a partnership.

Yes. And all of those activities are ongoing and on track. So in terms of clinical sites, protocol development, GMP production, compiling the necessary regulatory documentation. So that contributes to our timeframe that we put out publicly. So no change there, no concern at the moment with all those activities.

And on track with the communicated timelines of regulatory filing by the end of the year.

I got a couple more questions. One for Helen. So it's -- you and even the previous management have been kind of talking about potential partnerships over a couple of quarters now. At this point, what can you tell us in terms of where some of these discussions are? And if you would like to characterize the stage of the most advanced ones, where are they at? Are they like at the due diligence part, the exploratory part or you're almost in the hands of the lawyers and waiting for them to get things put into print?

Sure. So that's an obvious -- it's a good question, RK, but one I can't really answer as transparently as you would like. I would say, in the -- in our oncology conversations, obviously, clinical data that we have that Birgitte has talked about, particularly with EVX-01 has been very meaningful. But I think the -- to some extent, the validation of the whole field in terms of having -- seeing a company with a similar sort of program able to bring that forward to a registrational study has quite an impact. So I think whilst we've been doing various levels of dialogue and diligence, things have been somewhat -- there's sort of a wait to see how the field pans out. And I think, hence, Birgitte's comments earlier about the positive endorsement that this provides for all of us who have programs that are actually quite differentiated in terms of what they can offer and beyond melanoma as well. So amongst all of that, I think that the novelty around the ERV platform, the ability to find the conserved antigens from the dark genome has also piqued quite a bit of interest and coming in with a second program there in a highly -- very difficult to treat brain cancer accelerates that interest. So I've been doing BD for 20-odd years and things can go very fast when there's motivation and competition. And sometimes it can take 2 years. So I would say that we are in active conversations. And obviously, we'll be very happy to update when we can.

One last question from me. So Thomas, when we look at your operations in the first half, the cash use was about $8.3 million. And it looks like your quarterly burn rate is about like $4-plus million. So against the $14 million that you have in the bank now, can you walk us through your assumptions of how to get into second half '27? And are you expecting cash infusion either organically or inorganically?

Yes. No, good. Thanks, RK. So maybe first part of your question. So our cash out is not linear in the sense of each quarter just to extrapolate that. So of course, what we've seen and done in Q2, even in Q1 isn't just automatically to be extracted for the full year. There are some differences. Now we are and will expect to remain on that level that we've communicated also that roughly $14 million for the year. We might and I would expect to be even slightly lower than that. So it's not a round figure as such. We do have, of course, $14 million, as you rightfully have seen in -- on the bank account. Please also do remember, of course, that there are some normal fluctuations based on we are predominantly a DKK-based company versus the U.S. So there are some fluctuations from a pure ForEx perspective into that also. On top of that, so we still do expect that with the runway and with the focus on where we spend, how we spend that we still, as mentioned earlier, can confirm that we are in the second half of 2027. We will, of course, utilize the different things that we have available to us. One is also -- not that, that has gone in, I should start saying into the plan in terms of how we've communicated half 2 '27. But we do have an ATM facility that we can make use of. And actually, just as of yesterday, we also activated some of that ATM also in the market. So based, of course, on the positive news as we've seen and the volume in our price. So we will make use of those type of possibilities from an ATM perspective, plus, of course, when we also, at a point in time, announce deals or partnerships, that would certainly also add to it. But with the current straight runway and with our prioritized programs, we are very confident that we will go and get into the second half of 2027.

We are now going to take our next question. And this question comes from Debanjana Chatterjee from Jones.

This is [indiscernible] on for Debanjana. We had a few questions as well. So the first one that we wanted to ask was which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine that you are developing?

We haven't specified a specific population.

We are still working on identifying or -- we are still looking into different patient subsets and looking at the different ERV profiles and seeing what would be the most optimal set of the most optimal patient population. And further, we are, of course, also looking into standard of care and combination therapies, one should be a little bit cautious on combining a vaccine with chemotherapy. So there might be an option of going into those patients that are not benefiting from classical chemotherapy treatments. But we haven't entirely settled on the specifics around the clinical trial design.

Okay. And then as a quick follow-up, so what should we expect as the timeline for initiating that first-in-human clinical trial? And what are some key milestones that investors should be watching for before that trial initiates?

Yes. So we are early in the preclinical development. We've concluded on target discovery. So using our AI-Immunology for mining the patient data and now have a set of optimal ERVs that will be included in the EVX-05 vaccine. So we are screening. We have designed several different -- vaccine candidates are now experimentally testing those to select the lead candidate. And then it's the classical activities, IND-enabling activities prior to the first-in-human study. And as mentioned, we are working together with Duke University. We haven't communicated any firm timelines on this program as we need to see, first of all, lead selection before we start communicating timelines.

We're leveraging the same platform for EVX-04 and EVX-05 in terms of delivery methodology, which definitely will use the expertise and experience there from the GMP production side of things. So more to come on the timelines, but certainly, there's a lot we know about how to bring this kind of platform forward given the way we've done it already for EVX-04.

And then as a final question, so beyond glioblastoma, how broadly applicable do you believe the ERV targeting approach could be across various solid tumors? And then broadly, how does the EVX-05 fit into the long-term strategy of building that AI-driven oncology franchise?

Yes. So we have worked a lot in using AI-Immunology to mine patient data across several different indications. And we do see that there are certain patient subtypes where they have shared antigens. So there's definitely an option of applying this approach more broadly, but it's dependent on the profiles of those indications. But definitely more options for scaling this into other solid tumors and also hematologic malignancies.

And I think what's interesting is that often where there's not a high mutational burden, I think that there often is a high ERV frequency, and that's what we've been looking into. So often where there isn't an opportunity to take a personalized approach forward because of low mutational burden, that doesn't seem to be the case with the ERVs. And so more to come on that as we've been teasing this. So we think it really does broaden out the opportunity in terms of what we -- the cancer vaccine approach for novel targets.

[Operator Instructions] There seems to be no further questions for today. So I will hand the call back to Helen for closing remarks.

Thank you, and thank you, everyone, for listening in today and for the excellent questions that we've had. We're really excited about the operational -- the momentum that we've been able to deliver, about the interest in the programs coming in on the back of really exciting times for personalized cancer vaccines in the whole field. So exciting things to come, and we look forward to updating you further in the second half of the year. Thank you.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.